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Drug Safety and Teratogenicity Assessment in Pregnancy

Individual assessment based on PLLR has come to the fore instead of the FDA category system.

Written by: Saygı Hospital Health Guide Editorial Board
Last updated:

This content has been compiled by the Saygı Hospital Health Guide Editorial Board and is periodically reviewed by a specialist physician.

References (5)

This content is for informational purposes only and does not constitute medical advice. You can book an appointment at our Kadın Hastalıkları ve Doğum department. Book Appointment →

What is Drug Safety and Teratogenicity Assessment in Pregnancy?

Drug safety assessment in pregnancy is performed according to gestational week, dosage, duration, maternal benefit-risk ratio, and alternative options. The FDA's old A-X category system has been replaced by the Pregnancy and Lactation Labeling Rule (PLLR) system.

Risk databases include reliable sources such as Reprotox, LactMed, MotherToBaby, the Teratology Information Service (TIS), and UpToDate. Limitations of human data for each drug should be considered.

Preconception planning is important for women using drugs for chronic illness. Drug substitution, lowest effective dose, monotherapy preference, and discontinuation strategies for long half-life drugs are determined on a patient basis.

Symptoms

Chronic disease drug requirement
New-onset symptom treatment
Acute disease exacerbation
Over-the-counter drug use
Herbal supplements
Substance use disorders

Risk Factors

Use of known teratogens
High-dose and long-term therapy
Polypharmacy
Multidrug use
Inadequate-information OTC use
First trimester critical period

When to See a Doctor?

If you experience any of the following symptoms, seek medical attention promptly:

  • For preconception drug evaluation
  • To review existing drugs after pregnancy diagnosis
  • For safe drug selection in new symptom treatment
  • In acute disease exacerbation

Treatment Methods

01
Preconception counseling
02
Drug selection according to PLLR labeling
03
Switch to non-teratogenic alternatives
04
Low-dose and monotherapy protocols
05
Reprotox and LactMed database queries
06
Multidisciplinary MFM-pharmacology council

Which Department to Visit?

You can visit our Kadın Hastalıkları ve Doğum department for these complaints. Our specialist physicians will create the most suitable treatment plan for you.

Learn About Kadın Hastalıkları ve Doğum Department

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Health Disclaimer: The information on this page is prepared for general informational purposes only. It does not replace medical diagnosis and treatment. Please consult your physician for your complaints. Saygı Hospital does not accept responsibility for actions taken based on the information on this page.